2'-chloroacetoacetanilide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976-01-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable for reliability but not in detail documented. Study report meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Not applicable.

GLP compliance:

no

Remarks:

GLP-guidelines not yet in force at date of the study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2'-chloroacetoacetanilide

EC Number:

202-269-1

EC Name:

2'-chloroacetoacetanilide

Cas Number:

93-70-9

Molecular formula:

C10H10ClNO2

IUPAC Name:

2'-chloroacetoacetanilide

Details on test material:

Physical state: solid

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Fasted (24 hours) albino rats were used in this study. Weights 200 - 300 grams.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

The product under test was placed in a glass syringe and introduced through the esophagus into the stomach with a stainless steel catheter.

Doses:

6 dose groups (males & females) + control group (males & females) with dosages of:
- 4'000 mg/kg
- 8'000 mg/kg
- 10'000 mg/kg
- 12'500 mg/kg
- 16'000 mg/kg
- 32'000 mg/kg

No. of animals per sex per dose:

5 per sex per dose
5 per sex per control group

Control animals:

yes

Details on study design:

A group of approximately 70 albino male and female rats, fasted for twenty-four hours were employed to establish an LD50 range for each product
under test.
Young adult rats which had not been used for previous test purposes were assigned to various dose levels at random. Both sexes were equally
distributed.
The product under test was placed in a glass syringe and introduced through the esophagus into the stomach with a stainless steel catheter.
Animals on the same dosage level were then placed in a common cage with free access to food and water. The animals were observed daily for a
two week period.
No postmortem, or histopathology examinations were performed in this particular study

Statistics:

No data available.

Results and discussion

Preliminary study:

No preliminary test performed.

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD0

Effect level:

4 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

11 600 mg/kg bw

Based on:

test mat.

95% CL:

9 700 - 14 000

Effect levels 3

Sex:

male

Dose descriptor:

LD100

Effect level:

16 000 mg/kg bw

Based on:

test mat.

Effect levels 4

Sex:

female

Dose descriptor:

LD0

Effect level:

10 000 mg/kg bw

Based on:

test mat.

Effect levels 5

Sex:

female

Dose descriptor:

LD50

Effect level:

12 400 mg/kg bw

Based on:

test mat.

95% CL:

11 100 - 13 900

Effect levels 6

Sex:

female

Dose descriptor:

LD100

Effect level:

16 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at dose concentrations of 4000 mg/kg in males. Animals were found dead at 8000 mg/kg on day 4 and above (>8000 -
32000 mg/kg) in male rats.
No mortality was observed at dose concentrations of 4000 - 10000 mg/kg in females. Animals were found dead at 12500 mg/kg and above (>12500 -32000 mg/kg) in female rats.
Details are given in the table below.

Clinical signs:

other: Male rats: unkempt coats were noted for 36-48 hours at 4000 mg/kg. At levels of 8000 mg/kg, 10000 mg/kg and 12500 mg/kg, lethargy was accompanied with spasmodic movements, nasal hemorrhage and unkempt coats. Survivors appeared normal by the ninth day. Th

Gross pathology:

No Postmortem, or histopathology examinations were performed in this particular study.

Other findings:

No other findings.

Any other information on results incl. tables

Mortality:

Dose Level (mg/kg)	No. of deaths (males)	Number of deaths (females)
4000	0	0
8000	1 (at day 4)	0
10000	1 (at day 1)	0
12500	3 (2 at day 1 & 1 at day 6)	3 (2 at day 1 & 1 at day 2)
16000	5 (2 at day 1; 1 at day 2; 1 at day 3 & 1 at day 5))	5 (at day 1)
32000	5 (at day 1)	5 (at day 1)

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The LD50 for male albino rats is 11600 mg/kg bw and for female albino rats 12400 mg/kg bw in the acute toxicity study.

Executive summary:

The study was performed 1976, before GLP- and OECD-testing guidelines were available and in force. A group of approximately 70 albino male and female rats, fasted for twenty-four hours were employed to establish an LD50 range for each product under test. Young adult rats which had not been used for previous test purposes were assigned to various dose levels at random. Both sexes were equally distributed. Body weight of the rats were 200- 300 grams at the beginning of the study. The product under test was placed in a glass syringe and introduced through the esophagus into the stomach with a stainless steel catheter. Animals on the same dosage level were then placed in a common cage with free access to food and water. The animals were observed daily for a two week period. No postmortem, or histopathology examinations were performed in this particular study.

1. Clinical observations:

Unkempt coats were noted in male and female rats dosed at 4000 mg/kg and sluggish, impaired locomotion in females dosed at 4000 and 8000 mg/kg. Lethargy was accompanied with spasmodic movements, tremors and nasal hemorrhage in male in female rats dosed at 8000 mg/kg - 12500 mg/kg. The animals dosed at 16000 mg/kg were extremely lethargic, almost comatose, with spasmodic movements, nasal hemorrhage

and unkempt coats. Comas and oculo-nasal hemorrhage preceded death at 32000 mg/kg.

2. Mortality:

Death animals were observed at dose levels of 8000 mg/kg and above; for details refer to the above mentioned table.